MAUDE manufacturer profile
TERUMO EUROPE N.V · FMI
MAUDE profile for Needle, Hypodermic, Single Lumen
Key facts
| Manufacturer | TERUMO EUROPE N.V |
|---|---|
| Manufacturer group | TERUMO EUROPE N.V. |
| Product code | FMI |
| Product code name | Needle, Hypodermic, Single Lumen |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Consequences Or Impact To Patient, Foreign Body In Patient, Material Separation, Break, No Clinical Signs, Symptoms or Conditions, Insufficient Information Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1